Tigereye O300

GUDID 00851354004493

The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

AVINGER, INC.

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• Primary Device ID: 00851354004493
• NIH Device Record Key: 1c0d4ea4-7b4c-4a0b-b6c0-5686c0edf6a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tigereye
• Version Model Number: O300
• Catalog Number: O300
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com
• Phone: 650 241 7030
• Email: customerservice@avinger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201330

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00851354004493]

Radiation Sterilization

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Radiation Sterilization

[00851354004493]

Radiation Sterilization

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Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

[00851354004493]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-22
• Device Publish Date: 2023-03-14

Devices Manufactured by AVINGER, INC.

• 00851354004509 - Lightbox L3: 2024-02-06 The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the de
• 00851354004578 - Pantheris LV: 2024-02-06 The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F
• 00851354004554 - Tigereye ST: 2023-08-01 The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions
• 00851354004493 - Tigereye: 2023-03-22The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
• 00851354004493 - Tigereye: 2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu
• 00851354004417 - Pantheris SV: 2019-08-12 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature
• 00851354004004 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
• 00851354004028 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
• 00851354004042 - Kittykat II: 2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It